Abstract
Objective
To evaluate the effect of a 6-week washout period on intraocular pressure (IOP) following
long-term monotherapy prostaglandin use.
Design
Prospective, randomized, controlled, single-centre, single-blinded, parallel-group
clinical study.
Participants
Subjects aged >18 years diagnosed with open-angle glaucoma or open-angle glaucoma
suspects based on elevated IOP in one or both eyes, using monotherapy topical latanoprost,
bimatoprost, or travoprost once daily.
Methods
Subjects were prospectively randomized to continue prostaglandin analogue (PGA) monotherapy
(control group) or discontinue PGA monotherapy (washout group) for 42 days. IOP was
measured at day 0 (day of randomization), 7, 21, and 42.
Main Outcome Measure
Mean IOP (mm Hg) ± standard deviation.
Results
154 eyes (87 participants) completed the study, with 69 eyes (39 participants) in
the control group and 85 eyes (48 participants) in the washout group. In the control
group, day 0 IOP (14.64 ± 2.68 mm Hg) did not significantly differ from IOP at days
7 (14.25 ± 3.01 mm Hg), 21 (14.57 ± 2.61 mm Hg), and 42 (14.78 ± 2.30 mm Hg) (all
p > 0.30). In the washout group, mean IOP values at days 7 (16.19 ± 3.80 mm Hg), 21
(17.28 ± 3.55 mm Hg), and 42 (17.84 ± 3.31 mm Hg) were significantly greater than
those at day 0 (14.48 ± 1.94 mm Hg) and day-matched control group values (all p < 0.002). In the washout group, 24.7% of eyes had a day 42 IOP ≥21 mm Hg. No eyes
in the control group had a day 42 IOP ≥21 mm Hg.
Conclusions
Six weeks of PGA washout after long-term monotherapy resulted in a small but statistically
significant IOP increase. Majority of washout group participants maintained an IOP
lower than 21 mm Hg after the 6-week washout duration. (https://clinicaltrials.gov/ identifier, NCT03534882)
Résumé
Objectif
Évaluer l'effet d'un congé thérapeutique de 6 semaines sur la pression intraoculaire
(PIO) dans le cadre de l'administration à long terme d'une prostaglandine en monothérapie.
Nature
Étude clinique prospective, comparative, randomisée à simple insu et à groupes parallèles
réalisée dans un seul centre.
Participants
Des sujets âgés > 18 ans qui ont fait l'objet d'un diagnostic de glaucome à angle
ouvert ou chez lesquels on soupçonnait la présence d'un tel glaucome en raison de
la hausse de la PIO dans un œil ou les 2 yeux et qui instillaient un collyre (latanoprost,
bimatoprost ou travoprost) en monothérapie une fois par jour.
Méthodes
Les patients ont fait l'objet d'une randomisation prospective en 2 groupes : poursuite
de l'administration de l'analogue de la prostaglandine (APG) à titre de monothérapie
(groupe témoin) ou cessation de l'APG en monothérapie (groupe congé thérapeutique)
pendant 42 jours. La PIO a été mesurée au jour 0 (jour de la randomisation) de même
qu'aux jours 7, 21 et 42.
Principal paramètre de mesure
PIO moyenne (mm Hg) ± écart-type.
Résultats
Au total, 87 participants (154 yeux) ont poursuivi l’étude jusqu’à la fin : 39 participants
(69 yeux) dans le groupe témoin et 48 participants (85 yeux) dans le groupe congé
thérapeutique. Au jour 0, la PIO dans le groupe témoin (14,64 ± 2,68 mm Hg) ne différait
pas significativement de la PIO mesurée le jour 7 (14,25 ± 3,01 mm Hg), le jour 21
(14,57 ± 2,61 mm Hg) et le jour 42 (14,78 ± 2,30 mm Hg; p > 0,30 pour l'ensemble des
mesures). En revanche, la PIO moyenne dans le groupe congé thérapeutique mesurée au
jour 7 (16,19 ± 3,80 mm Hg), au jour 21 (17,28 ± 3,55 mm Hg) et au jour 42 (17,84
± 3,31 mm Hg) était significativement supérieure à la PIO enregistrée au jour 0 (14,48
± 1,94 mm Hg) et à la PIO mesurée les mêmes jours dans le groupe témoin (p < 0,002
pour l'ensemble des mesures). Dans le groupe congé thérapeutique, la PIO de 24,7 %
des yeux se chiffrait à ≥ 21 mm Hg au jour 42. Aucun œil du groupe témoin n'a atteint
une PIO ≥ 21 mm Hg au jour 42.
Conclusions
L'arrêt d'un APG pendant 6 semaines dans le cadre d'une monothérapie de longue durée
a entraîné une hausse faible, mais statistiquement significative de la PIO. La majorité
des patients du groupe congé thérapeutique ont conservé une PIO inférieure à 21 mm
Hg après les 6 semaines de cessation du traitement. (https://clinicaltrials.gov/; numéro d’étude : NCT03534882)
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Article Info
Publication History
Published online: November 08, 2019
Accepted:
August 29,
2019
Received in revised form:
July 1,
2019
Received:
May 12,
2019
Footnotes
Presented at the Canadian Ophthalmology Society Annual Meeting, Ottawa, Ontario, Canada, June 18, 2016, American Glaucoma Society annual Meeting, Fort Lauderdale, Florida, USA, March 3, 2016.
Identification
Copyright
© 2019 Canadian Ophthalmological Society. Published by Elsevier Inc. All rights reserved.
